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Summary
Overall ClinSpark User permissions are managed within the User Profile and cover 3 levels:
A Role/Roles are to be assigned to User(s)
In case of a multi-site customer, users can be restricted to certain Sites only
Users can be restricted to certain Studies only
Default Settings
A newly created User will have no Study and Site restrictions assigned. This means they will have access to all Studies and Sites by default.
Additionally, new New users will have no assigned Roles. To be able to log into ClinSpark, users need at least one Role assigned to their User Profile. Their User Role(s) will allow them to perform access certain areas and functions based on the assigned Role Actions within ClinSpark.
Restrict User Access to specific Sites
To restrict .
A newly created User will also have no Study and/or Site restrictions applied. For certain use cases this may be desirable, especially within early phase workflows. However it’s often necessary to apply additional restrictions to certain sites and studies.
There are some approaches you can consider in managing “default” user access (setting up new users) for Studies and Sites.
Allow access to all Studies and Sites, then further refine with restrictions on user profile
Prevent access by enforcing that at least one study or site be restricted on user profile
Requiring study and/or site restrictions for users can be controlled with the “Require restrictions” settings in the User Profile:
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When the “Require study restrictions?” setting is enabled for a User, they must have at least one study restricted to their profile in order to log in and access the system. This setting enforces a check done at login. Without any studies restricted to their profile, they will be unable to login.
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When the “Require site restrictions?” settings is disabled for a User, they will have access to features and data for all sites at login. However if this setting is enabled, they will only be able to access sites unless you restrict access them to specific Sites via their profile.
Manage User Access to specific Sites
You can use the “Restricted Sites” section in a User Profile to manage user access to Sites.
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If the “Require Site Restrictions?” setting is disabled for the User, leaving the “Restricted Sites” section blank will give the User access to all Sites. If the “Require Site Restrictions?” setting is enabled for the User, you must add at least one Site that the User should have access to.
To manage User Access per Site:
To restrict allow User access using the User Profile settings, go to Administration > Users, search for the desired User and click on their name to access their User Profile.
In the “Sites” section, click the green “Add” button.
Select the desired Site from the dropdown and tick the “Recruitment Restriction?” tickbox for User who will only perform recruitment-related actions within the Site.
Click “Save” to continue.
Repeat this for each Site that the User should have access to.
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Manage User Access to
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Studies
To restrict manage User Access to Studies, you can user use their User Profile settings or a study specific User Access module (Study > Configure > User Access).
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Remember that the “Require study restrictions?” setting on a user profile is intended to check if the user is able to access studies at login. If this setting is enabled, and the user has no study restrictions, they will not be able to login. |
Using the User Profile settings to restrict access
This is the most common method for restricting users to specific studies.
To restrict User access using the User Profile settings, go to Administration > Users, search for the desired User and click on their name to access their User Profile.
In the “Restricted Studies” section, click the green “Add” button.
Select the desired Study from the dropdown and click “Save” to continue.
Repeat this for each Study that the User should have access to.
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Using the Study Specific Controls to restrict access
For customers that need to be able to control User have more fine-grained controls for user permissions on a per-Study level, there is a feature in Study > Configure > User Access to support this need. This Study specific User access layer
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If you are considering using the study specific ‘User Access’ features, please consider the following:
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Note that this feature set is opt-in per study, so it is typically used when needing to define and enforce very specific user and role configurations for a given study.
To restrict User access using the Study Configure modulestudy specific controls, select the desired Study in the Study selection dropdown at the top of the page.
Click on the “Study” menu and select “Configure”.
Scroll down to the section “User Access” and click on it to open the configuration optionsNavigate to Study > Configure > User Access section.
Click on the “Action” menu and select “Import”. The “Import Study Users” screen will open.
To search for the Users, you will need to apply the Site filter. All Users belonging to the Site will appear in a list.
Search for Users to import & manage by applying the “Site” and “Role” filters. For example: if a User has multiple Roles, but they had only been trained for some of them for this specific Study, apply the “Role(s)” filter and only add them for each specific Role that they had already been trained for. You can add other Roles for the User later on.
Select the “Users Active” tickbox to mark them as active on the Study immediately. Leave the tickbox unchecked, if you wish to “activate” them later.
Select all of the Users who are authorized to access the Study information from the list, by ticking the appropriate tickboxes.
Click “Save”. Users list will be populated in the “User Access” section. They will be able to perform all of their Roles (as configured in their User Profile) within this Study. You can always come back and Import more users, Edit or Delete the User Access using the “Action” menu.
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Please note how in this example, the User Roles are Data Collector and QC Nurse, but they had only been added to this Study as “Data Collector”:
You can later on modify one or more user’s specific status and role(s) in the study using the Action menu:
Import additional Users
Activate/Deactivate selected Users. Note only users that are flagged ‘Active’ can access the study.
Add/Remove Roles for selected Users
Remove users from study access
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User Access Hierarchy
Study specific settings will supersede specific User Profile Settings. This means:
User has access to a Study in their User Profile, but they are not added to the list of authorized users in the Study Configure module = User will not have access to the Study.
User has access to Study A in their User Profile (no additional restrictions are defined in Study Configure) and access to Study B on the Study Configure module = User will have access to Studies A and B.
Restrict User Roles for a specific Study
You can further restrict a user’s role within any given Study by using the Study Configure module. This could mean that the User has Roles X, Y and Z in their User Profile, but for Study A you wish to restrict them to just Roles X and Y.
To restrict User Roles for a Study, select the Study A from the Study dropdown at the top of the page.
Click on the “Study” menu, then select “Configure”.
Scroll down to the “User Access” section.
From the “Action” menu, select the “Import” option.
Select the desired Role(s) from the dropdown (Site filter is optional). A list of Users with the selected Role(s) (as configured in their User Profile) will be displayed. You cannot assign any new Roles to the User using the Study Configure module.
Select all of the Users you wish to grant access for by ticking the appropriate tickboxes.
Click “Save”. The Users will be added to the authorized Users list and restricted to the Role you have selected.
If you are considering using the Study Configure module to restrict User Roles for Users, please consider the following:
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